FDA Recall D-0007-2026

AvKARE · Pulaski, TN

Class II Ongoing 254 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x28 tablets blister cards per carton, Rx only, Manufactured for AvKARE, Pulaski, TN 38478. Carton NDC: 42291-565-84; Blister NDC: 42291-565-28

Lot / code: Lot # LF41138A; Exp 06/30/2027

Quantity: 2192 cartons

Reason for recall

Failed Content Uniformity Specifications

Recall record

Recall number: D-0007-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: U.S. Nationwide
Recall initiated: 2025-09-02
Classified by FDA Center: 2025-10-06
FDA published: 2025-10-15
Recalling firm: AvKARE
Firm location: Pulaski, TN

Drug identification

Brand name(s): NORGESTIMATE AND ETHINYL ESTRADIOL
Generic name(s): NORGESTIMATE AND ETHINYL ESTRADIOL
Manufacturer(s): AvKARE
NDC(s): 42291-565

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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